Rotarix Side Effects

Generic Name: rotavirus vaccine live oral

Please note - some side effects for Rotarix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Rotarix - for the Consumer

Rotarix

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rotarix:

Cough; decreased appetite; fussiness; increased crying or irritability; mild fever or vomiting; runny nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Rotarix:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; change in bowel movements; high fever; red eyes or mouth; severe or persistent crying; severe or persistent diarrhea, stomach pain, or vomiting; swelling of the hands or feet; swollen glands; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Rotarix Side Effects - for the Professional

Rotarix

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of Rotarix could reveal adverse reactions not observed in clinical trials.

Solicited and unsolicited adverse events, serious adverse events and cases of intussusception were collected in 7 clinical studies. Cases of intussusception and serious adverse events were collected in an additional large safety study. These 8 clinical studies evaluated a total of 71,209 infants who received Rotarix (N = 36,755) or placebo (N = 34,454). The racial distribution for these studies was as follows: Hispanic 73.4%, white 16.2%, black 1.0%, and other 9.4%; 51% were male.

Solicited Adverse Events: In 7 clinical studies, detailed safety information was collected by parents/guardians for 8 consecutive days following vaccination with Rotarix (i.e., day of vaccination and the next 7 days). A diary card was completed to record fussiness/irritability, cough/runny nose, the infant’s temperature, loss of appetite, vomiting, or diarrhea on a daily basis during the first week following each dose of Rotarix or placebo. Adverse events among recipients of Rotarix and placebo occurred at similar rates (Table 1).

Table 1. Solicited Adverse Events Within 8 Days Following Doses 1 and 2 of Rotarix or Placebo (Total Vaccinated Cohort)

	Dose 1		Dose 2
	Rotarix	Placebo	Rotarix	Placebo
	N = 3,284	N = 2,013	N = 3,201	N = 1,973
	%	%	%	%
Fussiness/irritabilitya	52	52	42	42
Cough/runny noseb	28	30	31	33
Feverc	25	33	28	34
Loss of appetited	25	25	21	21
Vomiting	13	11	8	8
Diarrhea	4	3	3	3

Total vaccinated cohort = all vaccinated infants for whom safety data were available.

N = number of infants for whom at least one symptom sheet was completed.

aDefined as crying more than usual.

bData not collected in 1 of 7 studies; Dose 1: Rotarix N = 2,583; placebo N = 1,897; Dose 2: Rotarix N = 2,522; placebo N = 1,863.

cDefined as temperature ≥100.4°F (≥38.0°C) rectally or ≥99.5°F (≥37.5°C) orally.

dDefined as eating less than usual.

Unsolicited Adverse Events: Infants were monitored for unsolicited serious and non-serious adverse events that occurred in the 31-day period following vaccination in 7 clinical studies. The following adverse events occurred at a statistically higher incidence (95% CI of Relative Risk excluding 1) among recipients of Rotarix (N = 5,082) as compared with placebo recipients (N = 2,902): irritability (Rotarix 11.4%, placebo 8.7%) and flatulence (Rotarix 2.2%, placebo 1.3%).

Serious Adverse Events (SAEs): Infants were monitored for serious adverse events that occurred in the 31-day period following vaccination in 8 clinical studies. Serious adverse events occurred in 1.7% of recipients of Rotarix (N = 36,755) as compared with 1.9% of placebo recipients (N = 34,454). Among placebo recipients, diarrhea (placebo 0.07%, Rotarix 0.02%), dehydration (placebo 0.06%, Rotarix 0.02%), and gastroenteritis (placebo 0.3%, Rotarix 0.2%) occurred at a statistically higher incidence (95% CI of Relative Risk excluding 1) as compared with recipients of Rotarix.

Deaths: During the entire course of 8 clinical studies, there were 68 (0.19%) deaths following administration of Rotarix (N = 36,755) and 50 (0.15%) deaths following placebo administration (N = 34,454). The most commonly reported cause of death following vaccination was pneumonia, which was observed in 19 (0.05%) recipients of Rotarix and 10 (0.03%) placebo recipients (Relative Risk: 1.74, 95% CI: 0.76, 4.23).

Intussusception: In a controlled safety study conducted in Latin America and Finland, the risk of intussusception was evaluated in 63,225 infants (31,673 received Rotarix and 31,552 received placebo). Infants were monitored by active surveillance including independent, complementary methods (prospective hospital surveillance and parent reporting at scheduled study visits) to identify potential cases of intussusception within 31 days after vaccination and, in a subset of 20,169 infants (10,159 received Rotarix and 10,010 received placebo), up to one year after the first dose.

No increased risk of intussusception following administration of Rotarix was observed within a 31-day period following any dose, and rates were comparable to the placebo group after a median of 100 days (Table 2). In a subset of 20,169 infants (10,159 received Rotarix and 10,010 received placebo) followed up to one year after dose 1, there were 4 cases of intussusception with Rotarix compared with 14 cases of intussusception with placebo [Relative Risk: 0.28 (95% CI: 0.10, 0.81)]. All of the infants who developed intussusception recovered without sequelae.

Table 2. Intussusception and Relative Risk With Rotarix Compared With Placebo

Confirmed Cases of Intussusception	Rotarix	Placebo
	N = 31,673	N = 31,552
Within 31 days of diagnosis after any dose	6	7
Relative Risk (95% CI)	0.85 (0.30, 2.42)
Within 100 days of dose 1a	9	16
Relative Risk (95% CI)	0.56 (0.25, 1.24)

 CI = Confidence Interval.

aMedian duration after dose 1 (follow-up visit at 30 to 90 days after dose 2).

Among vaccine recipients, there were no confirmed cases of intussusception within the 0- to 14-day period after the first dose (Table 3), which was the period of highest risk for the previously licensed oral live rhesus rotavirus-based vaccine.1

Table 3. Intussusception Cases by Day Range in Relation to Dose

	Dose 1		Dose 2		Any Dose
Day Range	Rotarix	Placebo	Rotarix	Placebo	Rotarix	Placebo
	N = 31,673	N = 31,552	N = 29,616	N = 29,465	N = 31,673	N = 31,552
0-7	0	0	2	0	2	0
8-14	0	0	0	2	0	2
15-21	1	1	2	1	3	2
22-30	0	1	1	2	1	3
Total (0-30)	1	2	5	5	6	7

Kawasaki Disease: Kawasaki disease has been reported in 18 (0.035%) recipients of Rotarix and 9 (0.021%) placebo recipients from 16 completed or ongoing clinical trials. Of the 27 cases, 5 occurred following Rotarix in clinical trials that were either not placebo-controlled or 1:1 randomized. In placebo-controlled trials, Kawasaki disease was reported in 17 recipients of Rotarix and 9 placebo recipients [Relative Risk: 1.71 (95% CI: 0.71, 4.38)]. Three of the 27 cases were reported within 30 days post-vaccination: 2 cases (Rotarix = 1, placebo = 1) were from placebo-controlled trials [Relative Risk: 1.00 (95% CI: 0.01, 78.35)] and one case following Rotarix was from a non-placebo-controlled trial. Among recipients of Rotarix, the time of onset after study dose ranged 3 days to 19 months.

Postmarketing Experience

The risk of intussusception with Rotarix has been evaluated in a hospital-based Postmarketing Active Surveillance Study (PASS) in a birth cohort of infants in Mexico. An interim analysis of this study suggests an increased risk of intussusception in the 31-day period following administration of the first dose of Rotarix [Relative Risk: 1.8 (99% CI: 1.0, 3.1)]. In this study, within the 31-day period after the first dose, most cases of intussusception occurred in the first 7 days.

Applying the relative risk observed from the interim analysis of the PASS in Mexico to estimates of background rates of intussusception in the US would approximate 0 to 4 additional cases of intussusception hospitalizations per 100,000 vaccinated infants within the 31 days after the first dose. In the first year of life, the background rate of intussusception hospitalizations in the US is approximately 34 per 100,000 infants.2

Worldwide passive postmarketing surveillance data also suggest that most cases of intussusception reported following Rotarix occur in the 7-day period after the first dose.

The following adverse events have been reported since market introduction of Rotarix. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination with Rotarix.

Gastrointestinal Disorders: Intussusception (including death), hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID).

Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpura.

Vascular Disorders: Kawasaki disease.

General Disorders and Administration Site Conditions: Maladministration.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included intussusception (including death), gastroenteritis, hematochezia, loss of appetite, diarrhea, vomiting, flatulence, abdominal pain, food regurgitation, and constipation. Post marketing experience has included gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID).

Dermatologic

Dermatologic side effects have included urticaria.

Nervous system

Nervous system side effects have included seizures, sleep disorder and somnolence.

Other

Other side effects have included dehydration, Kawasaki Disease, fever and fatigue.

Psychiatric

Psychiatric side effects have included fussiness/irritability and crying.

Respiratory

Respiratory side effects have included pneumonia, nasopharyngitis, otitis media, bronchiolitis, cough/runny nose, bronchospasm, upper respiratory tract infection, hoarseness, and rhinorrhea. Apnea has been reported in premature infants.

Genitourinary

Genitourinary side effects have included urinary tract infection.

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